For many products, equipment and machinery sold or supplied to the European Union, CE marking is a pre-requisite.
Here we’ll provide key information on this mark of conformity.
It’s a declaration made by the supplier that all applicable conformity assessment procedures have been completed and that the product conforms to EU Directives. There are numerous product categories presently covered including:
European Union directives - also known as the New Approach Directives - define “essential requirements” related to health, safety and environmental issues. All products covered by these Directives must be CE marked unless a specific Directive says otherwise. Note that the same product may be subject to several CE marking Directives.
Yes, CE marking is obligatory for products and equipment sold or supplied on the EU market. CE marking falls under European Law, as well as the national laws of each EU Member State.
For products and equipment sold or supplied to the United Kingdom market, UKCA marking applies, rather than CE marking.
Use of a CE mark is a Declaration of Conformity; it follows that a product should not be CE marked if there is no Directive in place for that product. When applicable, the CE mark should be attached to:
UKCA marking covers products and equipment in the following categories:
Some types of products and equipment are covered by CE marking but also have their own special rules. Check the EU’s official website for sector-specific guidance on the following areas:
CE marking is not required for products being sold outside the EU, Switzerland or Turkey. In other countries, different standards will need to be complied with, although these may be similar to CE marking requirements.
In the European market, there are some product categories to which CE marking does not apply.
These include, but are not exclusive to:
Only the manufacturer, or its authorised representative within the EEA may apply CE marking, which must take the form described in Directive 93/68/EEC. The manufacturer assumes ultimate responsibility for applying the mark, or the manufacturer may appoint an authorised representative who should be based within the EU to act on their behalf. This person or organisation, known as a European Authorised Representative, then assumes the responsibilities of the manufacturer.
Only once all assessment procedures covering conformity have been completed and the product is compliant.
Yes, the CE marking is always affixed by the manufacturer or by their authorised representative after the necessary conformity assessment procedure has been performed.
Usually, you would apply the CE mark directly onto a product or piece of equipment, or its packaging.
The CE mark might also be placed in the product manual for products and equipment, or in other supporting literature. This depends on the regulations in the Directive that applies to the particular product or equipment type.
There is never a 100 per cent guarantee that a product bearing the CE mark is safe. However, the obligations of the manufacturer are clear - by affixing the CE marking to a product, the manufacturer assumes full responsibility for its compliance with all applicable requirements in EU legislation.
It is the system behind CE marking that ensures its proper functioning. The entire system, consisting of manufacturers, importers, distributors, notified bodies and market surveillance authorities, has been strengthened through the new legislative framework, which aims to further reduce burdens on trade in the EU while, at the same time ensuring a high level of safety and protection of other public interests.
In most cases, equipment will not need to be CE marked after being modified. However, you may have to carry out conformity testing for a new CE mark if the modification:
Note that even if modified equipment doesn’t require a new CE mark, it will still need to be safe to use and meet PUWER requirements and be safe to use.
This document indicates that the product in question meets all the necessary requirements stipulated in the applicable directive. It can only be issued by the manufacturer or his representative, as detailed above.
Public authorities in EU Member States in cooperation with the European Commission.
It varies by Member State but economic operators may be liable to a fine and, in some circumstances, imprisonment. Products may be withdrawn or recalled from the market.
If you are a manufacturer who wants to get your products or equipment CE certified, speaking to IES is a good place to start. We offer a turnkey compliance testing service, helping manufacturers and OEMs test new, second hand and modified equipment.
We test your high-technology equipment against the requirements of the following three Directives:
Our assessments are carried out by experts with 30 years of experience in compliance testing, allowing you to achieve CE certification with complete confidence.
For details of our full service offering, case studies and testimonials - discover more about Compliance Testing from IES or contact us to discuss your requirements.